(89 days)
Not Found
No
The summary describes a light-cured resin sealant for dentures and does not mention any AI or ML components or functionalities.
No
The device is a coating material for dentures, intended to provide a smooth and glossy surface, not to treat or diagnose a disease or condition.
No
Explanation: The device is described as a "light-cured, transparent resin sealant for acrylic denture bases that produces a smooth, glossy surface finish on the denture." Its purpose is to physically modify the denture surface, not to provide any diagnostic information about a patient's health or condition.
No
The device is a physical material (resin sealant) that is applied to a denture base and cured with UV light. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a smooth, glossy surface finish on acrylic denture bases. This is a physical application to a medical device (a denture), not a test performed on a biological sample to diagnose a condition or provide information about a physiological state.
- Device Description: The description confirms it's a coating applied to a denture base.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
- Performance Studies: The performance studies focus on biocompatibility and physical performance (smoothness, glossiness), which are relevant to a dental material applied to a device, not an IVD.
Therefore, this device falls under the category of a dental material used in the fabrication or modification of a medical device (a denture), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Coating Material is a light-cured, transparent resin sealant for acrylic denture bases that produces a smooth, glossy surface finish on the denture.
Product codes (comma separated list FDA assigned to the subject device)
EBI
Device Description
Coating Material is a light-cured denture base coating that is composed of two liquids that are mixed prior to use, and then photo-polymerized by a UV light. The coated surface provides smoothness and glossiness to the surface of an acrylic denture base. The coated layer is transparent, so it does not affect the original color of the denture.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Extensive testing has been performed on the subject denture base resin to demonstrate compliance with ISO 7405:1997 Dentistry; Preclinical evaluation of biocompatibility of medical devices used in dentistry, Test methods for dental materials. The following testing has been performed to support substantial equivalence:
Biocompatibility –The biological safety of the Coating Material was evaluated in accordance with ISO 7405:2008, ISO 10993-1: 2009 and guidance document entitled Blue Book Memo, G95-1, Use of International Standard ISO-10993, and Biological Evaluation of Medical Devices: Part 1: Evaluation and Testing. Under these, for the stated indications for use, the device was classified as a permanent exposure (C), surface-contacting device in contact with mucosal membranes. The Coating Material biocompatibility was tested for the following with the final results.
- Cytotoxicity (MEM Elution Test) - The Coating Material was found to be noncytotoxic, and all test method acceptance criteria were met per ISO 10993-5.
- Skin Sensitisation (Guinea Pig Maximization) - Coating Material is considered to cause no sensitization under the experimental conditions of this study per ISO 10993-10.
- Intracutaneous Reactivity - Coating Material caused no signs of irritation, met the requirements of the test and is classified as not irritant per ISO 10993-10.
- Subchronic Toxicity - Coating Material is considered to not cause significant systemic toxicity under the experimental conditions of this study per ISO 10993-11.
- Genotoxicity (In Vitro Mammalian Chromosome Aberration Test) - Coating Material extract is considered to be non-clastogenic under the experimental conditions of this study per ISO 10993-3.
- Genotoxicity Bacterial Reverse Mutation (AMES) Test - Coating Material was considered non-mutagenic (non-genotoxic and non-clastogenic) under the experimental conditions of this study per ISO 10993-3.
Performance Bench Testing - It is confirmed that the Coating Material conforms to the required specifications and is suitable for its intended use. Performance testing includes:
- Coating applicability
- The properties of the coated surface
Risk Management – Risk Analysis was conducted according to ISO 14971, and the outcomes of these risks are considered acceptable, and that all potential risks have been mitigated to the lowest form.
The Coating Material meets all the requirements for the overall design, performance, and biocompatibility, confirming that the output meets the design inputs and specifications. The Coating Material passed all testing stated above as shown by the acceptable results obtained.
The Coating Material complies with the applicable voluntary standards for biocompatibility. The device passed all the testing in accordance with national and international standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Heraeus Kulzer, Inc., Palaseal® - K892452
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 27, 2015
Sun Medical Co., Ltd. c/o Ms. Carrie Hetrick Emergo Group 816 Congress Avenue, Suite 1400 Austin, Texas 78701
Re: K150511
Trade/Device Name: Coating Material Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: February 26, 2015 Received: February 27, 2015
Dear Ms. Hetrick:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150511
Device Name Coating Material
Indications for Use (Describe)
Coating Material is a light-cured, transparent resin sealant for acrylic denture bases that produces a smooth, glossy surface finish on the denture.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
510(k) Summary
for
Coating Material
1. Submission Sponsor
Sun Medical Co., Ltd. 571-2, Furutaka-cho Moriyama, Shiga 524-0044 Japan Phone: 81-77-582-9978 Fax: 81-77-582-9984 Contact: Mr. Yukihito Yukimune, Pharmaceutical Affairs Department Director
2. Submission Correspondent
Emergo 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: (720) 833.4113 Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Carrie Hetrick, Senior Consultant, Regulatory Affairs Email: project.management@emergogroup.com
3. Date Prepared
May 19, 2015
4. Device Identification
| Trade/Proprietary Name: | Coating Material |
|---|---|
| Common/Usual Name: | Coating Material |
| Classification Name: | Denture Relining, Repairing, or Rebasing Resin |
| Classification Regulation: | 21 CFR § 872.3760 |
| Product Code: | EBI |
| Device Class: | Class II |
| Classification Panel: | Dental |
5. Legally Marketed Predicate Device(s)
Heraeus Kulzer, Inc., Palaseal® - K892452
6. Device Description
Coating Material is a light-cured denture base coating that is composed of two liquids that are mixed prior to use, and then photo-polymerized by a UV light. The coated surface
4
provides smoothness and glossiness to the surface of an acrylic denture base. The coated layer is transparent, so it does not affect the original color of the denture.
7. Indication for Use Statement
Coating Material is a light-cured, transparent resin sealant for acrylic denture bases that produces a smooth, glossy surface finish on the denture.
8. Substantial Equivalence Discussion
The following table compares the Coating Material to the predicate device with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.
| Manufacturer | Sun Medical Co., Ltd. | Heraeus Kulzer, Inc. | Significant Differences |
|---|---|---|---|
| Trade Name | Coating Material | Palaseal® | |
| 510(k) Number | K150511 | K892452 | Not applicable |
| Product Code | EBI | EBI | Same |
| Regulation | |||
| Number | 21 CFR § 872.3760 | 21 CFR § 872.3760 | Same |
| Regulation | |||
| Name | Denture Base Resin | Denture Base Resin | Same |
| Device | |||
| Description | Coating Material is a light- | ||
| cured denture base | |||
| coating that is composed | |||
| of two liquids that are | |||
| mixed prior to use, and | |||
| then photo-polymerized | |||
| by a UV radiation. | Palaseal® is a light-curing, | ||
| transparent sealing resin | |||
| that bonds to any denture | |||
| materials, temporary | |||
| crowns, and bridges. The | |||
| patient receives an | |||
| aesthetically and | |||
| functionally comfortable | |||
| denture. | Similar with minor | ||
| variation - Both are | |||
| transparent, light-cured | |||
| resins intended to seal | |||
| acrylic dentures | |||
| Indications for | |||
| Use | Coating Material is a light- | ||
| cured, transparent resin | |||
| sealant for acrylic denture | |||
| bases that produces a | |||
| smooth, glossy, and | |||
| functionally comfortable | |||
| denture. | Photocuring lacquer for | ||
| sealing dentures and | |||
| temporary crowns and | |||
| bridges based on PMMA- | |||
| resin. | Similar with minor | ||
| variation- both are a | |||
| coating material for | |||
| dentures. The predicate is | |||
| also intended for use in | |||
| temporary crowns and | |||
| bridges. | |||
| Area of | |||
| application | - Surface sealing of | ||
| dentures |
- Surface sealing of
dentures after
finishing | - Surface sealing of
dentures - Surface sealing of
dentures after
finishing - Surface sealing of
temporary crowns
and bridges | Similar with minor
variation - both are
intended for sealing
dentures. They differ in
that the Palaseal is also
intended to be used as a
surface sealant of
temporary crowns and
bridges |
| Chemical
composition | Acrylic compounds,
solvent, and a photo
initiator | Multifunctional
methacrylate, methyl
methacrylate, and a photo
initiator | Similar - The devices are
composed of similar
acrylic raw materials, have
the same intended use
and technological |
Table 5A - Comparison of Characteristics
5
| Manufacturer | Sun Medical Co., Ltd. | Heraeus Kulzer, Inc. | Significant Differences |
|---|---|---|---|
| Polymerization | |||
| (Curing) Method | Cured by Ultraviolet (UV) | ||
| radiation | Cured by Ultraviolet (UV) | ||
| radiation | Same | ||
| Components | Two-Component System - | ||
| Liquid A and Liquid B | One-component System - | ||
| Denture Lacquer | Differ - The subject device | ||
| is a two-part liquid system | |||
| that requires the user to | |||
| mix, and the predicate is | |||
| one part liquid system. | |||
| Appearance | Smooth, high gloss surface | ||
| with no evidence of | |||
| cracking or peeling after | |||
| being light-cured | Smooth, high gloss surface | ||
| with no evidence of | |||
| cracking or peeling after | |||
| being light-cured | Same | ||
| Application | Applied with a brush or by | ||
| dipping into a tub | Applied with a brush | Similar - Both may be | |
| applied with a brush | |||
| Biocompatibility | ISO 10993-1, ISO 7405 | ISO 10993-1, ISO 7405 | Same |
The subject and predicate devices are liguid formulations that contain acrylic compounds, solvent, and an initiator. All of the components of the Coating Material have similar to the predicate device. Coating Material requires the user to mix the two liquid components, while the predicate is a one-liquid product. The curing mechanism of the devices is polymerization of uncured acrylic monomers. This reaction is caused by a photo initiator system.
The Coating Material shares the same or similar indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate device. All of the components have been used in legally marketed devices. The formulations have not been changed in ways that may adversely impact device performance.
9. Non-Clinical Performance Data
Extensive testing has been performed on the subject denture base resin to demonstrate compliance with ISO 7405:1997 Dentistry; Preclinical evaluation of biocompatibility of medical devices used in dentistry, Test methods for dental materials. The following testing has been performed to support substantial equivalence:
Biocompatibility –The biological safety of the Coating Material was evaluated in accordance with ISO 7405:2008, ISO 10993-1: 2009 and guidance document entitled Blue Book Memo, G95-1, Use of International Standard ISO-10993, and Biological Evaluation of Medical Devices: Part 1: Evaluation and Testing. Under these, for the stated indications for use, the device was classified as a permanent exposure (C), surface-contacting device in contact with mucosal membranes. The Coating Material biocompatibility was tested for the following with the final results.
- Cytotoxicity (MEM Elution Test) - The Coating Material was found to be noncytotoxic, and all test method acceptance criteria were met per ISO 10993-5.
- Skin Sensitisation (Guinea Pig Maximization) - Coating Material is considered to cause no sensitization under the experimental conditions of this study per ISO 10993-10.
6
- Intracutaneous Reactivity - Coating Material caused no signs of irritation, met the requirements of the test and is classified as not irritant per ISO 10993-10.
- . Subchronic Toxicity - Coating Material is considered to not cause significant systemic toxicity under the experimental conditions of this study per ISO 10993-11.
- Genotoxicity (In Vitro Mammalian Chromosome Aberration Test) - Coating Material extract is considered to be non-clastogenic under the experimental conditions of this study per ISO 10993-3.
- . Genotoxicity Bacterial Reverse Mutation (AMES) Test - Coating Material was considered non-mutagenic (non-genotoxic and non-clastogenic) under the experimental conditions of this study per ISO 10993-3.
Performance Bench Testing - It is confirmed that the Coating Material conforms to the required specifications and is suitable for its intended use. Performance testing includes:
- . Coating applicability
- . The properties of the coated surface
Risk Management – Risk Analysis was conducted according to ISO 14971, and the outcomes of these risks are considered acceptable, and that all potential risks have been mitigated to the lowest form.
The Coating Material meets all the requirements for the overall design, performance, and biocompatibility, confirming that the output meets the design inputs and specifications. The Coating Material passed all testing stated above as shown by the acceptable results obtained.
The Coating Material complies with the applicable voluntary standards for biocompatibility. The device passed all the testing in accordance with national and international standards.
10. Clinical Performance Data
There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years and there are no adverse reactions. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.
11. Statement of Substantial Equivalence
By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device.
The Coating Material has the same or similar intended use, indications, principles of operation, and technological characteristics as the predicate devices. Coating Material, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate devices in terms of intended use, design, materials, and function.